Senior Regulatory Affairs Specialist – Hardgoods

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee, analyze, and convey updates regarding applicable federal, regional, and international safety standards, test standards, and regulatory requirements for hardgoods and instrumentation product lines.

• Conduct regulatory compliance evaluations for new products, modifications, replacement parts, and lifecycle changes to facilitate compliant development, launch, and sustained marketability.

• Examine technical and compliance documentation, including critical component lists, NRTL safety reports, certification records, compliance reports, and instrument manuals.

• Collaborate with product teams, contract manufacturers, NRTLs, regional regulatory teams, quality, procurement, finance, and other stakeholders to assist with certification, testing, and documentation requirements.

• Monitor certification expiration dates, renewals, testing schedules, factory inspections, and related activities to mitigate compliance delays or interruptions in market access.

• Aid in tracking the regulatory budget, processing purchase orders, coordinating invoices, and managing fees for testing, certifications, inspections, and related compliance activities.

⛳️ Requirements

• Background in regulatory affairs, product compliance, product stewardship, quality, engineering compliance, or a similar role supporting hardgoods, instrumentation, or food safety product lines.

• Familiarity with instrument safety, EMC, emissions, certification processes, and regulatory compliance expectations for marketed products.

• Experience in reviewing technical documentation such as NRTL reports, safety reports, critical component lists, certification records, manuals, or compliance assessments.

• Excellent written and verbal communication skills, capable of clearly articulating regulatory requirements, documentation necessities, and compliance updates to both internal and external stakeholders.

• Proven organizational skills and attention to detail, with the ability to juggle multiple priorities, timelines, purchase orders, budget activities, and renewal deadlines.

• Capability to work independently and collaboratively while exercising sound judgment in escalating compliance risks, certification timing issues, or budget concerns appropriately.

🏝️ Benefits

• An opportunity to contribute to product safety, regulatory compliance, and ongoing market access for hardgoods, instrumentation, and food safety product lines.

• A collaborative, cross-functional work environment that offers chances to partner with product teams, contract manufacturers, NRTLs, regional regulatory teams, and global stakeholders.

• Continuous training and development aimed at enhancing technical regulatory knowledge, certification expertise, and lifecycle compliance capabilities.

• Opportunities to engage in new product development, product modifications, certification renewals, and global compliance activities within a dynamic business setting.

• A standard benefits package, wellness resources, and development support aligned with applicable company policies and business practices.